Health Condition 1: null- Asthma
Conditions
Interventions
Intervention1: Salbutamol & Beclometasone Pressurized Inhalation: 2 puffs thrice daily for 10 days
Control Intervention1: Salbutamol + Beclometasone HFA spray: 2 puffs thrice daily for 10 days
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female outpatients aged >=18 to 2. Clinical diagnosis of asthma for at least 6 months prior to screening and FEV1 >=70 % to 3. Patients able to demonstrate at least 12% improvement in FEV1 and 200ml after 30 minutes (±10mins) after inhalation of Salbutamol 400μg 4. Patient willing to perform all study related procedures including the use of study inhalers, Spirometry and peak flow meter and willing to complete the patient diary
Exclusion criteria
Exclusion criteria: 1. COPD as defined by the European Respiratory Society (ERS) â?? Consensus Statement; 2. Patients with more than 10 packs/year of cigarettes history and current smokers 3. Patients with a history of hypersensitivity to salbutamol/beclomethasone and or any other ingredients 4. History of near fatal asthma and/or admission in intensive care unit because of asthma 5. Female subjects who are pregnant, nursing or planning a pregnancy during the study 6. Patient has any uncontrolled systemic disease or patient has had any major surgery within 4 weeks of study start 7. History of alcohol and/or substance abuse within 12 months prior to the Screening Visit 8. Subjects who have participated in another investigational drug or device research study within 30 days of enrollment 9. Subjects who are using any medication or has any disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference between groups in FEV1 value at the End of Treatment VisitTimepoint: 10 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of asthma symptoms (symptom scores)Timepoint: 10 days;Mean change in PEFR from baseline to end of treatmentTimepoint: 10 days;Need for short acting beta 2 agonist as rescue inhalationTimepoint: 10 days;Nocturnal asthma (nocturnal awakening because of asthma)Timepoint: 10 days;Patient and Investigator global impressionTimepoint: 10 days | — |
Countries
India
Contacts
Public ContactDr Shailendra Sachan
Glenmark Pharmaceuticals Ltd
Outcome results
None listed